Delirium
Conditions
Brief summary
The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.
Detailed description
To examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient population. To examine the feasibility and acceptability of videoconferencing (VCU Health Zoom), EHR screening, and VCU and VCU Health infrastructure (REDCap, OnCore) for rural participant recruitment and research participation, remote HealthCare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., Agitation, Delirium, ICU length of stay, number ventilator days, sedation/opioid medication usage).
Interventions
DEVICEWeighted Blanket
Weighted Blanket is an occupational therapy modality which has been associated with significant increases in grounding, orientation to reality, soothing, and quality of life.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot study that will be conducted in a convenience sample of adult medicine ICU patients. Healthcare providers caring for enrolled patients will also be asked to complete questionnaires related to experience providing care to patients enrolled in the study. Patient participants will be enrolled in the study. Healthcare providers will not be considered enrolled as questionnaires are voluntary and anonymous and these healthcare providers will not be consented (waiver of consent through IRB) for participation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria: * 18 years of age or older. * Requiring ICU level of care. * Have a primary medical diagnosis. * Proficient in English. Patient
Exclusion criteria
* BMI less than 18.5. * Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia). * Known pregnancy. * Prisoners. * Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury. * Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury. * Paralysis effecting an area the weighted blanket will cover. * Current neuromuscular blocking agent. * Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine). * History of claustrophobia reported by patient and/or their legally authorized representative (LAR). * Fever of 37.5°C (99.5°F). * Limited English proficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Participants Experience Survey | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days | Study Participants will be asked to complete a survey describing their experience with using the weighted blanket upon discharge from the ICU or if they stop using the weighted blanket, to determine if participants felt using the weighted blanket was beneficial to their overall health improvement. The full name is "Participant Weighted Blanket Satisfaction Survey." A likert scale (1-5) was used with 1 being less satisfied and 5 being higher satisfaction. There were 6 questions total. Total score was averaged. |
| LAR Experience Survey | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days | LAR will complete survey describing his/her perspective of the participant's use of the weighted blanket to improve family member's health outcome. LAR will complete survey after participant has been discharged from ICU or participant is no longer using the weighted blanket. |
| Nurse and Provider Experience Survey | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days | The nurse and healthcare provider will complete surveys once their patient has completed the use of the weighted blanket describing whether they felt the weighted blanket improved the health outcome of their patients. The full name is "Nurse \& Provider Weighted Blanket Experience Survey" A likert scale (1-5) was used with 1 being less satisfied and 5 being higher satisfaction. There were questions total. Total score was averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Total ICU Length of Stay (Days) | From participant enrollment until participant is downgraded from ICU level of care | Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days). |
| Analysis of Total ICU Length of Stay on Study (Days) | From participant enrollment until participant is downgraded from ICU level of care or until participant withdraws from study (whichever occurs first) | Study Team will collect data daily and conduct analysis of total ICU Length of Stay on Study (Days) |
| Analysis of Total Number of Ventilator Days During Current ICU Admission | From current ICU admission date until participant is downgraded from ICU level of care, an average of 4 days. This measure includes any vent days prior to the participant being enrolled in the study | Study Team will collect data daily and conduct analysis of total Number of Ventilator Days. |
| Analysis of Total Number of Ventilator Days on Study | From study enrollment date until participant is downgraded from ICU level of care, an average of 4 days. This measure only looks at vent days while enrolled and does NOT include vent days prior to enrollment | Study Team will collect data daily and conduct analysis of total number of Ventilator Days on Study. |
| Richmond Agitation Sedation Scale (RASS) | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days | Study Team will collect data daily and conduct analysis of the daily chart review data. RASS is a 10-point tool (ranging from +4 combative to -5 unarousable) used in critical care to assess a patient's level of alertness, agitation, or sedation, helping healthcare providers guide therapy and prevent over/under-sedation, with 0 being alert and calm, positive scores indicating agitation, and negative scores indicating sedation, assessed by observation, verbal, and then physical stimuli as needed. |
| Hours of Blanket Usage Per Day (24 Hours) | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days | Study Team will collect data daily and conduct analysis of the Blanket Usage Log. Number collected reflects hours per day that blanket was utilized by study participant. Range was 0-24. Zero meaning no usage and 24 meaning constant usage for the 24-hour period. |
| Confusion Assessment Method for the ICU (CAM-ICU) | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days | Study Team will collect data daily and conduct analysis of data from the CAM-ICU, a rating scale used by bedside clinicians to assess delirium for patients in the intensive care unit. The CAM-ICU evaluates the presence delirium. Score range is 0-1 where 0 is no delirium present and 1 is delirium present, with 0 being the more desired outcome. |
Countries
United States
Participant flow
Pre-assignment details
Healthcare providers completing questionnaires did so voluntarily and anonymously. They were not consented for the study (waiver of consent through IRB) and no details were collected about the providers.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
None listed